Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery
The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• History of type 1 diabetes for at least one year
• Age 18-45 years
• HbA1c \<10%
‣ BMI 18-35 kg/m2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day.
⁃ Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM.
⁃ On stable regimen of non-diabetic medications for the last 6 months.
⁃ All screening labs within normal limits or not clinically significant.
⁃ Ability to take oral medication and be willing to adhere to the study drug/placebo for 12 weeks.
⁃ For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 2 weeks after the end of CIR-0602K administration.
⁃ For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study intervention.
⁃ Agreement to adhere to Lifestyle Considerations throughout study duration.